Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C Virus

In brief

Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA level (\< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in a 2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA \< lower limit of detection \[15 IU/mL\] from Weeks 4 through 12) received an additional 12 weeks of PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV. Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400 mg plus PEG+RBV for 12 weeks.

Key facts

Study ID

NCT01188772

Run by

Gilead Sciences

People needed

147

Starts

2010-08-01

Expected to finish

2012-05-01

Last updated by the study team

2014-04-21

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females aged 18 to 70 years, inclusive, at screening
• Documented chronic genotype 1, 2, or 3 HCV infection
• No previous treatment with HCV antiviral mediations
• Body mass index (BMI) of greater than 18 kg/m2, but not exceeding 36 kg/m2.
• Liver biopsy obtained within 3 years prior to the Day 1 visit, with a fibrosis classification of non-cirrhotic as judged by a local pathologist
• Willing to refrain from beginning any new exercise regimens during the first 3 months of the study
• Fasting blood glucose ≤ 300 mg/dl and/or glycosylated hemoglobin (HbA1c) ≤ 8
• History of hypertension only if managed effectively on a stable regimen of two or fewer antihypertensives for at least three (3) months prior to screening

You may not qualify if…

• Females who were breastfeeding
• Males and females of reproductive potential who are unwilling to use an "effective", protocol-specified method(s) of contraception during the study
• Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab.
• History of any other clinically significant chronic liver disease
• Treatment with herbal/natural remedies with antiviral activity within 30 days prior to baseline.
• Significant history of immunologically mediated disease, cardiac or pulmonary disease, seizure disorder or anticonvulsant use
• History of ascites, variceal hemorrhage, hepatic encephalopathy, or conditions consistent with decompensated liver disease
• Use of medications associated with QT prolongation within 30 days prior to dosing
• Screening electrocardiogram (ECG) QTc value greater than 450 ms and/or clinically significant ECG findings
• Personal or family history of Torsade de pointes.
• Positive results for drugs of abuse test at screening
• Abnormal hematological and biochemical parameters, including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 5 times the upper limit of the normal range (ULN)
• History of major organ transplantation with an existing functional graft
• History of uncontrolled thyroid disease or abnormal thyroid-stimulating hormone (TSH) levels at screening
• Clinically significant drug allergy to nucleoside/nucleotide analogs
• History or current evidence of psychiatric illness, immunologic disorder, pulmonary, cardiac disease, seizure disorder, cancer or history of malignancy that in the opinion of the investigator makes the patient unsuitable for the study
• History of systemic antineoplastic or immunomodulatory treatment within 6 months prior to dosing, or the expectation of such treatment during the study

Where it is running

• Alabama Liver and Digestive Specialists — Montgomery, Alabama, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• SCTI Research Foundation — Coronado, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Dr. Jay Lalezari — San Francisco, California, United States
• Dr. Natalie Bzowej — San Francisco, California, United States
• Dr. David Nelson — Gainesville, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Gastrointestinal Specialists of Georgia — Marietta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Dr. Mark Sulkowski — Lutherville, Maryland, United States
• Liver Research Center Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Kansas City Gastroenterology and Hepatology — Kansas City, Missouri, United States
• Dr. Bruce Bacon — St Louis, Missouri, United States
• North Shore University Hospital — Manhasset, New York, United States
• Dr. Ira Jacobson — New York, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Dr. Jama Darling — Chapel Hill, North Carolina, United States
• Dr. Raj Reddy — Philadelphia, Pennsylvania, United States
• Columbia Gastroenterology and Liver Associates — Columbia, South Carolina, United States
• Dr. Eric Lawitz — San Antonio, Texas, United States
• Digestive Disease Institute Virginia Mason Medical Center — Seattle, Washington, United States
• Fundacion de Investigacion de Diego — Santurce, Puerto Rico, Puerto Rico

Full record on ClinicalTrials.gov

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